21 CFR 800.20

21 CFR 800.20 - Sample plans and test mthods for leakage defects, medical gloves.

This is the federal guideline used to outline the test method used to detect water leakage on examination and surgical gloves. During the 1900s, HIV awareness caused the FDA and CDC to recommend precautions for protecting healthcare professionals. This recommendation included having healthcare workers wear medical exam gloves whenever handling patients where exposure to blood or bodily fluids is high. For this reason, medical gloves became regulated to ensure the exam gloves provided an adequate barrier to bloodborne pathogens.

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